NCT04941729终止不适用
A Prospective, Multi-center, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the OR3O™ Dual Mobility System Versus Conventional Single Bearing Design Total Hip System in Primary Total Hip Arthroplasty (THA) Procedures.
Smith & Nephew Medical (Shanghai) Ltd4 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年6月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months
研究概览
简要总结
The purpose of this study is to compare OR3O™ Dual Mobility System to a conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Data collected in this study will be used to support National Medical Products Administration (NMPA) regulatory approval of OR3O™ Dual Mobility System in China as well as to support and maintain product registration in global markets.
Primary Objective: Assess safety and efficacy of the OR3O™ Dual Mobility System in Primary THA at 1 year postoperative.
Secondary Objective(s): Assess safety and efficacy of the OR3O™ Dual Mobility System and compatible components in Primary THA up to 2 years after surgery.
Other Objective(s): Assess the hip dislocation and hospital readmission up to 2 years after device implantation.
4 study sites in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a suitable candidate for implanting the OR3O™ Dual Mobility System or single-bearing design Total Hip System in primary total hip replacement in the Investigator's judgement.
- •Subject is skeletally mature in the Investigator's judgement.
- •Subject is 18 - 80 years old (inclusive).
- •Subject is receiving total hip replacement for the first time on the affected hip.
- •Subject has any of the following conditions:
- •Advanced degeneration of the hip joint as a result of degenerative, post-traumatic, or rheumatoid arthritis(RA);
- •Fracture or avascular necrosis of the femoral head;
- •All forms of osteoarthritis(OA);
- •Patients with hips at risk of dislocation;
- •Femoral neck fracture or proximal hip joint fracture.
- •Subject provides written informed consent for study participation using an Ethical Committee (EC) approved consent form before any study procedures are performed, including pre-operative data review and/or collection of data on electronic Case Report Forms (eCRFs).
- •Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
- •Subjects with preoperative HHS ≤ 79 (fair or worse category).
排除标准
- •Subject has conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant, e.g.:
- •blood supply limitations;
- •insufficient quantity or quality of bone support, e.g., osteoporosis, metabolic disorders which may impair bone formation, radioactive bone disease, tumor around hip joint, and osteomalacia;
- •infections or other conditions which may lead to increased bone resorption.
- •Subject has dysplasia of hip joint with CROWE Grade III, IV.
- •Subject has weak constitution or failing to endure the surgery due to other diseases of the body.
- •Subject has bodily disease(s) that may interfere with THA survival or outcome.
- •Subject has life expectancy of less than 2 years.
- •Subject has mental or neurological conditions which impair the subject's ability or willingness to restrict activities that may put the affected limb at risk.
- •Subject has physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities.
- •Subject has neuromuscular dysfunctions (paralysis, myolysis and abductor muscle weakness) which will cause unstable hip joint or abnormal gait after surgery.
- •Subject has a mental or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
- •Subject has an active infection - systemic or at the site of intended surgery.
- •Subject has a Body Mass Index ≥ 40.0 kg/m².
- •Subject has a known allergy to any component of the devices used in the study.
- •Subject is pregnant or breast feeding.
- •Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation.
- •Subjects that are expected with poor compliance.
- •Subjects with complications of other diseases are limited to participate in the research, not able to comply with the follow-up or have impact on scientific integrity.
- •Subjects with preoperative HHS ≥ 80 (good to excellent category).
- •Subject has other diseases or conditions that investigator considers not appropriate to participate in the study.
研究组 & 干预措施
Study Arm (dual mobility)
Experimental
OR3O™ Dual Mobility in subjects who undergo Primary THA.
干预措施: OR3O™ - Dual Mobility System (Device)
Controlled Arm (conventional)
Active Comparator
A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA.
干预措施: Conventional (Device)
结局指标
主要结局
Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months
时间窗: 12 months
Number of participants with an excellent (≥ 90) or good (80-89) Harris Hip Score at 12 months postoperative (No/Yes). The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best).
次要结局
- Survivorship of the OR3O™ Dual Mobility System(6 weeks, 3 months, 6 months, and 12 months)
- Harris Hip Score (HHS)(Preoperative, 6 weeks, 6 months, and 12 months)
- EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score(Preoperative, 6 weeks, 6 months, and 12 months)
- EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score(Preoperative, 6 weeks, 6 months, and 12 months)
- Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.)(Preoperative, 6 weeks, 6 months, and 12 months)
- Radiographic Assessment - Implant Position/Orientation(6 months and 12 months)
- Radiographic Assessment - Implant Subsidence/Migration(6 months and 12 months)
- Radiographic Assessment - Heterotopic Ossification(6 months and 12 months)
- Radiographic Assessment - Radiolucencies(6 months and 12 months)
- Radiographic Assessment - Osteolysis(6 months and 12 months)
- Radiographic Assessment - Implant Loosening(6 months and 12 months)
- Radiographic Assessment - Stress Shielding(6 months and 12 months)
- Radiographic Assessment - Periprosthetic Fractures(6 months and 12 months)
研究者
研究点 (4)
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